As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
One of these firms is Santa Cruz Produce Inc., out of Nogales, AZ. This import company is on notice from the FDA for not having FSVPs for a number of imported food products.
In a March 8, 2023, warning letter, the FDA described a Nov. 14, 2022, Foreign Supplier Verification Program (FSVP) inspection of Santa Cruz Produce, Inc. in Nogales, AZ.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a.
The significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, the firm did not develop an FSVP for any of the foods they import, including each of the following:
- Fresh Mango
- Fresh Kabocha Squash
- Fresh Kabocha Squash
Another company is the Milky Way International Trading Corporation out of Norwalk, CA. This import company is on notice from the FDA for not having FSVPs for a number of imported food products.
In an April 14, 2023, warning letter, the FDA described a Nov. 4 and Nov. 17, 2022, Foreign Supplier Verification Program (FSVP) inspection of Milky Way International Trading Corporation in Norwalk, CA.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a.
The significant violations are as follows: The firm did not develop, maintain, and follow an FSVP. Specifically, the firm did not develop an FSVP for the following foods:
- Mushroom, Common (Agaricus Bisporus), Pieces And Stems, Sliced
- Artichoke (Microgreen) and Artichoke (Leaf & Stem Vegetable)
- Asparagus (Microgreen) and Asparagus (Leaf & Stem Vegetable)
- Jerusalem Artichoke (Root & Tuber Vegetable)
- Corn (Vegetable)
- Orange (Citrus)
- Pear (Core Fruit)
- Peach (Pit Fruit)
Asparagus (Microgreen) and Asparagus (Leaf & Stem Vegetable) - Fruit Cocktail, Mixed Fruits
- Peach, Jam, Jelly, Preserves, Marmalade, Butter Or Candied
- Other Fruits And Subtropical/Tropical Fruit, Mixed, Toppings And Syrups
- Mixed Fruit, N.E.C.
- Peach (Pit Fruit)
- Horseradish,
- Bamboo Shoots (Microgreen) and Bamboo Shoots (Leaf & Stem Vegetable)
The firm did not meet the requirements to perform foreign supplier verification activities for the products they import. Specifically, they did not meet the requirement to, before importing a food from a foreign supplier, determine and document which verification activity or verification activities, and the frequency with which such verification activity or activities must be conducted, are needed to provide adequate assurances that hazards requiring a control in the food they import have been significantly minimized or prevented.
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